Senior Global Engineering Specialist - Bulk

Century Center

7+ years reliability engineering experience
Bulk biologics upstream and downstream support
Gmp regulatory compliance knowledge
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets

Job Summary

  • This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets.
  • The position requires deep technical leadership in managing the lifecycle of bioreactors, filtration systems, and clean utility infrastructure while ensuring strict GMP compliance.
  • Candidates will partner with global teams to drive continuous improvement initiatives that enhance equipment uptime, reliability, and process robustness.

Matching Summary

This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets.

Skills & Requirements

Must-have

  • 7+ years reliability engineering experience
  • Bulk biologics upstream and downstream support
  • GMP regulatory compliance knowledge
  • Root cause analysis and CAPA implementation
  • Maintenance of bioreactors and chromatography systems

Nice-to-have

  • Six Sigma or Lean principles knowledge
  • Experience with global matrix organizations
  • Strong cross-cultural collaboration skills
  • Innovation mindset for advanced diagnostics
  • MBA or Master's degree preferred

Key Requirements

  • Bachelor's degree in Engineering required
  • 7+ years in reliability or maintenance engineering
  • 5+ years supporting bulk biologics manufacturing
  • Experience managing globally distributed teams
  • Knowledge of FDA 21 CFR Parts 210/211 and EU GMP

Work Rights

Not specified

Tailored Resume

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